LAUNCH: 12 November 2013 Section 1 Introduction 2

LAUNCH: 12 November 2013 Section 1 Introduction 2

LAUNCH: 12 November 2013 Section 1 Introduction 2 3 Introduction Background Housekeeping

- Fire exits - Breaks/Refreshments - Toilets Workbooks Ground Rules Attendees #Hello My Name is ... and personal expectations 4 Workshop Objectives 1. To provide an overview of the national open disclosure

programme . 2.To build understanding as to how the principles of open disclosure link into existing HSE Quality, Patient Safety and Risk procedures/frameworks 3. To provide best practice guidance on how to implement the principles of open disclosure. 4. To provide information and training via case scenarios and role play on delivering on the principles of open disclosure. 5 Objectives

(continued) 5. To demonstrate the benefits for patients/service users, their families and staff. 6. To practice the key skills required when engaging in open disclosure discussions 7. To explore the key components involved in the open disclosure process 8. To provide awareness on the resources available. 6 Workshop Programme

An overview of open disclosure. Open disclosure the drivers The patient/service user perspective The Clinicians perspective The Disclosure Process Summary and close 7 DVD: And you werent even going to tell me 8

Section 2 An Overview of Open Disclosure 9 The reality of poor communication Our family did not get open disclosure. We felt excluded and badly treated and none of the undertakings to give us answers were honoured. We pursued the legal route for three years but that

was fraught with lack of conclusions and we feared for our financial security. 10 Definition of Open Disclosure? An open, consistent approach to communicating with patients when things go wrong in healthcare. This includes expressing regret for what has happened, keeping the patient informed, providing feedback on investigations and the steps taken to prevent a recurrence of the adverse

event. (Australian Commission on Safety and Quality in Health Care) 11 What is Open Disclosure/Open Communication? Open disclosure describes the way staff communicate with patients who have experienced harm during health care this

harm may or may not be as a result of error/failure CARE Open disclosure is a discussion and an exchange of information that may take place in one conversation or over one or more meetings COMPASSION

TRUST 12 CARE COMPASSION KINDNESS TRUST LEARNING EMPATHY

13 What is an Adverse Event? An incident which resulted in harm, that may or may not be the result of error HSE Incident Management Framework - Guidance 2018 14 Adverse events:

How common are they? Studies conducted in North America, Britain, Europe, Australia and New Zealand have shown that the percentage of adverse events occurring in hospitals is between 3 and 17% with an average of 10%. Most medical errors are related to system problems, not individual negligence or misconduct, and are preventable. Fifty per cent, or one in every two, adverse events can be prevented. 15 The Irish National Adverse Event Study 2009 published

2016 1574 patients (53% women) 8 hospitals The prevalence of adverse events in admissions was 12.2% Over 70% of events were considered preventable. Two-thirds were rated as having a mild-to-moderate impact on the patient, 9.9% causing permanent impairment and 6.7% contributing to death. 16 10. Continuity of care

1. Acknowledgement 2. Truthfulness, timeliness and clarity of communication 9. Confidentiality Principles of Open Disclosure 8. Clinical

governance 7. Multidisciplinary responsibility 6. Risk management and systems improvement 3. Apology / expression of regret 4. Recognising

the expectations of service users 5. Professional Support Why are these principles being advocated? They form the basis of a professional and ethical response A Blame and Shame culture can interfere with finding the contributory factors and root cause of an adverse outcome To promote a Just culture International evidence demonstrates that effective open disclosure does improve the patient experience

(MPS Mastering Adverse Outcomes Workshop) 18 Quote from Atul Gawande (Surgeon) We look for medicine to be an orderly field of knowledge and procedure but it is not. It is an imperfect science, an enterprise of constantly changing knowledge, uncertain information, fallible individuals and at the same time lives on the line.

(Complications: A surgeons notes on an imperfect science 2003) 19 Section 3 Open Disclosure The Drivers 20 Recommendations by the Patient Safety Commission 2008

National Standards to be developed and implemented Legislation to provide legal protection Open communication training for all healthcare professionals Support and counselling programmes Research in to the impact on patients and families. 21 Our natural instinct Open disclosure represents the best of Irish healthcare. I think our instinct is to be open with patients and open disclosure guides staff to do what

they know is right even in difficult circumstances when an error has occurred Dr Philip Crowley: National Director of Quality Improvement HSE QID January 2018 22 Open Disclosure: The Drivers Open disclosure is the professional, ethical and human response to patients involved in/affected by adverse events/adverse outcomes in healthcare It is what patients want

and expect Learning from past experiences 23 Open Disclosure: The Drivers HSE Policy Professional and Regulatory 1. NMBI - code 2. Medical Council - code 3. HIQA - standards 4. CORU - code 5. Mental Health Commission

6. Pre Hospital Emergency Care Council 7. Pharmaceutical Society of Ireland (PSI) - code 24 Open Disclosure: The Drivers The Department of Health: Government Policy Indemnifying Bodies: SCA/MPS/MDU/MEDISEC Royal Colleges: RCSI, RCPI, ICO, ICGP, Faculty of Radiologists WHO

Media 25 HSE A Patient can expect open and appropriate communication throughout your care especially when plans change or if something goes wrong. (National Healthcare Charter: You and Your Health Service, 2010 - Revised 2012.) Open and honest communication (Open Disclosure) is initiated as soon as practicable after the incident has been identified. The planned review process has been described

and communicated to all persons affected. (HSE Incident Management Framework 2018) 26 Department of Health Open Disclosure can be viewed as an integral element of patient safety incident management and it is government policy that a system of open disclosure is in place and supported across the health system (2018) January 2018 27

State Claims Agency At the heart of open disclosure lies the concept of open, honest and timely communication. Patients and relatives must receive a meaningful explanation following an adverse event. (Ciarn Breen, Director of the SCA 2015) 28 Medical Protection Society

29 MEDISEC "At Medisec, we welcome and support the principles of Open Disclosure, and encourage our members to engage with patients in an open, honest and transparent manner when things go wrong. We believe that timely and clear communication with a patient about an adverse event benefits all parties. Patients are facilitated by understanding what occurred and receiving an apology, if appropriate. Open disclosure also represents a vital learning opportunity for the doctor concerned, leading to safer and more robust practice going forward." ( 2018)

30 Medical Council Patients and their families, where appropriate, are entitled to honest, open and prompt communication with them about adverse events that may have caused them harm. Guide to The Professional Conduct and Ethics for Registered Medical Practitioners 2016) 31 The Nursing and Midwifery

Board of Ireland Safe quality practice is promoted by nurses and midwives actively participating in incident reporting, adverse event reviews and open disclosure (Code of Professional Conduct and Ethics for Registered Nurses Midwives December 2014) 32 HIQA National Standards for Safer Better Healthcare 2012

Standard: 3.5: Service providers fully and openly inform and support service users as soon as possible after an adverse event affecting them has occurred, or becomes known and continue to provide information and support as needed. 33 CORU: If a service user suffers harm, speak openly and honestly to them as soon as possible

about what happened, their condition and their ongoing care plan (The Codes for Dietitians 2014, Speech and Language Therapists 2014 and Occupational Therapists 2014) 34 Pre Hospital Emergency Care Council (PHECC) PHECC wholly endorses the HSE principles of open disclosure. PHECC is committed to the process of open disclosure as included in the Education and Training Standards since 2007. We believe that the open disclosure process encourages the reporting of adverse events which leads

to a manifestation of the patients autonomy and ultimately leads to opportunities for systems improvement and delivery of the highest standards of care delivery. In addition PHECC is committed to information being available following the incident review as being an essential component of an open disclosure policy. (statement from PHECC April 2015) 35 Mental Health Commission The Mental Health Commission fully endorses Open Disclosure and communicating authentically, compassionately and respectfully with service users, families and staff involved in patient safety incidents.

The Commission and HIQA jointly developed National Standards for the Conduct of Reviews of Patient Safety Incidents (2017). The National Standards cover reviews of patient safety incidents which fit into a services overall incident management process; this includes reporting, open disclosure and notification to external bodies. (2018) 36 Legislation to support Open Disclosure Protective legislative provisions in Part 4 of the the Civil Liability Amendment Act 2017 1. Open disclosure: (a) shall not constitute an express or implied admission of fault or liability

(b) shall not, notwithstanding any other enactment or rule of law, be admissible as evidence of fault or liability and (c) shall not invalidate insurance or otherwise affect the cover provided by such policy 37 Provisions of legislation 2. Information provided, and an apology where it is made, shall not (a)constitute an express or implied admission, by a health

practitioner, of fault, professional misconduct, poor professional performance, unfitness to practise (a)be admissible as evidence of fault, professional misconduct, poor professional performance, unfitness to practise, in proceedings to determine a complaint, application or allegation 38 Legal Services Regulations Act 2015 This act contains the following protections for an apology in clinical negligence claims: (1) An apology made in connection with an allegation of clinical negligence (a) shall not constitute an express or implied admission of fault or liability, and

(b) shall not, despite any provision to the contrary in any contract of insurance and despite any other enactment, invalidate or otherwise affect any insurance coverage that is, or but for the apology would be, available in respect of the matter alleged. 2) Despite any other enactment, evidence of an apology referred to in subsection (1) is not admissible as evidence of fault or liability of any person in any proceedings in a clinical negligence action.. 39 Section 4 The Patient/Service Users Perspective

40 Exercise 1 Watch the DVD (approximately 4-5 minutes) Focus on the patient Mrs Ling As you are watching it think about what the patients needs are. What does the patient require/expect from her GP during the consultation? What does the patient expect following the consultation in relation to her ongoing care? 41

The Open Disclosure Process using the MPS A.S.S.I.S.T Model of Communication: A Acknowledge problem and impact S Sorry express regret S Story hear patients story and summarise back to them I Inquire seek questions to be answered, provide answers, give information, S Solution seek patients ideas on the way forward - agree a plan T Travel avoid abandonment continued care increased contact.

42 Do patients want to know? At least 98% want to be told the truth Hobgood et al 2005, Mazor et al 2004 43 What do patients / service users want?

Respect Honesty To be informed about their situation by someone who is knowledgeable about it To have their questions answered in language they understand Empathy Dedicated attention Professionalism Competent, efficient service

To be listened to (and heard) To be updated in a timely manner 1. A timely and comprehensive explanation of what happened and why 2. Someone to acknowledge and apologise if things went wrong

3. A reassurance that steps have been taken to ensure the event will not happen again Basic courtesy / friendliness To be taken seriously Follow-through Benefits for Patients/Service Users Why do patients sue? To get answers

The need for acknowledgement and apology Patients felt rushed Felt less time spent/ignored The attitude of staff Patients wanted their perception of the event validated 46 Why do patients sue?

The experience of second harm To seek financial compensation To enforce accountability To correct deficient standards of care To try to prevent a recurrence of the event 47 Quote from a Patient Advocate Open disclosure is not about blame.

It is not about accepting the blame. It is not about apportioning blame. It is about integrity and being truly professional And the reason: You hold our lives in your hands and we, as patients, want to hold you in high regard. 48 Exercise 2: Watch the DVD same scenario as before (Exercise 1) GP consultation now using the A.S.S.I.S.T model Record the terminology used by the Dr which

applied to the various components of the A.S.S.I.S.T model. 49 Exercise 3:

Read the case scenario provided. In your allocated groups of three you will take turns in playing the role of (a) Doctor, (b) Patient and (c) Observer You will be allocated 5 minutes for each role play. Do not be concerned if you have not completed the consultation. At the end of 5 minutes provide feedback on the consultation using the A.S.S.I.S.T Model. You will then swap roles. There will be a general feedback session at the end of the session when all three persons have experienced the role of the Doctor, Patient and Observer. 50

Section 5 The Clinicians Perspectives and Considerations 51 Exercise 4: Watch the DVD Consider the feelings and emotions of the doctor whose patient is being referred to by their medical colleague. Consider that you are this doctor.

Write down all the feelings you may be experiencing and your possible reactions to this conversation. 52 The six recognised stages of staff reaction following an adverse event 1. Chaos: Error realised and recognised. How and why did it happen. Care for the patient. 2. Intrusive reflections: Re-evaluate the event. Haunted reenactments of the event. Self isolation. 3. Restoring personal integrity: Managing gossip Questioning trust. Fear. 4. Enduring the inquisition: Realisation of seriousness.

Wonder about repercussions. Who can I talk to? 5. Obtaining emotional first aid: Seeking personal and professional support. Where can I turn to for help? 53 The six recognised stages of staff reaction following an adverse event: 6. Moving OnDropping Out, Surviving or Thriving: Despite a desire to move on, many professionals find it difficult to do so. This stage has three potential paths: Dropping Outchanging professional role, leaving the

profession or moving to a different practice location. Survivingperforming at the expected performance levels (doing OK) but continue to be affected by the event. Thrivingmaking something good out of the adverse event. 54 Why disclosure is difficult Culture: Historic Medical Culture of Non disclosure

Institutional Barriers: Blame and Shame approach no institutional support or mechanisms to facilitate disclosure Fear of litigation Fear concerning professional advancement

Fear with regard to reputation Fear of being reported to professional body Fear of the Media Fear of the patients/familys response

Financial concerns Uncertainty with regard to extent of information to be disclosed Lack of training and guidance for healthcare professionals 55 Benefits for staff

University of Michigan Health System 2002, Adopted full disclosure policyMoved from, Deny and defend to Apologise and learn when were wrong, explain and vigorously defend when were right and view court as a last resort August 2001-August 2007 Ratio of litigated cases : total reduced from 65-27%. Average claims processing time reduced from 20.3 months to 8 months. Insurance reserves reduced by > two thirds. Average litigation costs more than halved. Savings invested into patient safety initiatives.

57 The ASSIST Me Model of Staff Support Information for staff on: The potential normal reactions to what is an abnormal event How to help yourself How to support a colleague /peer using the ASSIST ME model Advice on when to seek professional assistance i.e. GP/EAP/OH

58 Resources: Employing organisation: Work Colleagues/Peers/Managers GP EAP/Occupational Health

Indemnifying bodies/Royal Colleges The HSE Policy for Preventing and Managing Critical Incident Stress 2012 developed by the National Health and Safety Advisers Group. The HSE and State Claims Agency staff support booklet 2013: Supporting staff following an adverse event: The ASSIST ME model

59 Section 6 The Disclosure Process 60 Levels of Disclosure Criteria for determining the appropriate level of response Lower-level response

Near misses and no-harm incidents No permanent injury No increased level of care (e.g. transfer to operating theatre or intensive care unit) required No, or minor, psychological or emotional distress Higher-level response Death or major permanent loss of function Permanent or considerable lessening of body function Significant escalation of care or major change in clinical management (e.g. admission to hospital, surgical intervention, a higher level of care, or transfer to intensive care unit) Major psychological or emotional distress At the request of the patient Reference: Open disclosure: Just-in-time information for healthcare providers Australian Open Disclosure Framework 2013

61 Preparation: A preliminary team discussion to establish the known facts To establish the facts takes time, not all facts need to be established prior to meeting the patient/family.

Think ahead and plan responses to questions which may arise A key contact person is assigned, Consider if additional supports are required? e.g. interpreter, assisted decision making 62

Considerations: Does the CEO/GM know that a disclosure meeting is happening..? Should they be there? Are there any other members of the healthcare team that need to know... e.g. Clinical Director Director of Nursing Allied Healthcare Public Health. 63 The Disclosure Team Lead Discloser Ideally the patients consultant/most

responsible person (MRP) involved in their care. Deputy Discloser To assist, ensure patient/ family understands. Key Contact Links with patient/ family Keeps them informed Meet and Greet Scribe Confidentiality, Shorthand, Legibility. 64 Deciding who should lead the discussion: A decision as to who leads the disclosure meeting must be made early.

Take account of- Experience/ training/communication skills/impact of the event on staff involved. Is the lead consultant/MRP the most appropriate, is he/she able to lead, especially if the outcome was catastrophic? Multiple specialities involved..? 65 Where to disclose: Preparation again essential Key contact to liaise with patient/family Meet and greet patient and family at predetermined location Consideration to off site meeting

Well ventilated room Refreshments Bleeps, mobiles off. 66 What to disclose Expression of regret/apology Factually correct information Steps taken or planned to try to prevent a recurrence of the event. Practical support mechanisms, contact names, information pamphlets, support networks. What happens next. Care plan review etc. 67

Documentation: Essential to ensure continuity and consistency Imperative that details of the adverse event are documented in the clinical record including the details of clinical care provided. The salient points of the open disclosure meeting should be documented in the patient record including the exact wording and context of any apology given. Non-clinical communications to be kept in a separate file i.e. risk reviews, minutes of meetings etc Refer to pre-during and post documentation checklist in guidelines and on website 68

Disclosing another clinicians error Consider ethical duty/responsibility Patients and families come first - rights to honest, open and transparent communication - compassion - difficulties in disclosure should not stand in the way - ensuring correct clinical management of the patients condition

Explore Do not ignore! - turn towards involved colleague - colleague to colleague discussion - obtain the facts do not rush to judgement - frame the conversation to minimize defensiveness curiosity opposed to manner body language - tone - establish what happened - discuss and agree the way forward clinical management - reporting, disclosure etc - seek assistance from the organisation if necessary. accusations

69 Common Pitfalls

Talking too much/negative body language Too many people involved in the disclosure meeting Failure to recognise the elements of a grief reaction Arguing or trying to prove you are right and over use of the word but e.g. I hear what you are saying but.. Failure to express enough empathy for the patient/family situation Use of medical jargon Focusing on points of disagreements rather than on points of solutions Failure to follow through on actions agreed. Lack of situational awareness Punctuality 70

Resources and further information www.opendisclosure.ie National documents Resources for clinicians, organisations and trainers Open disclosure site leads/group leads/CHO leads/NAS Leads Yammer.com support forum 71 Sample Language: Refer to workbook and guidelines

72 Open disclosure in specific circumstances Faculty of Radiology: Open disclosure guidelines for radiologists http://www.radiology.ie/wp-content/uploads/2012/05/Open-Disclosure-Fac ulty-of-Radiologists-V1.2-April-20161.pdf Open Disclosure of Health Care Acquired Infections (HCAI s)

73 Fact: Things go wrong and will continue to go wrong .. Adverse events happen to the best people in the best places none of us are immune. We must be honest with our patients, our colleagues and

with ourselves. Learning is difficult where transparency is absent. Transparency must involve an empathetic approach to the patients, staff and services involved in adverse events. 74 Contact Details: [email protected] [email protected] www.hse.ie/opendisclosure

Or www.opendisclosure.ie 75 Thank you for your time and attention.any questions ? 76

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